On October 8, 2019 Biodesix, Inc. the leader in lung cancer diagnostics, reported the appointment of internationally recognized lung cancer expert, James Jett, M.D., as Chief Medical Officer (Press release, Biodesix, OCT 8, 2019, View Source [SID1234540109]). Dr. Jett joins Steven Springmeyer, M.D. as co-CMO to support all aspects of the Company’s research, development and commercialization efforts. Today’s news comes as Biodesix continues to drive adoption of the recently launched Nodify XL2 proteomic nodule classifier.

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"Biodesix is a natural continuation of my gratifying career as a physician. I believe that the future of patient care in oncology and pulmonology should be designed and innovated with the patient experience as the highest priority"

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Dr. Jett joins Biodesix from Oncimmune Ltd., where he served as the Chief Medical Officer. His career includes work as a Professor of Medicine at the Mayo Medical School and the University of Pittsburgh. Dr. Jett has also served as a consultant for the National Cancer Institute in Bethesda, and he was the Editor in Chief of the Journal of Thoracic Oncology from 2006-2013. His work on academic editorial boards includes Chest, Respiratory Medicine, and the American Journal of Respiratory and Critical Care Medicine.

In addition to all aspects of the company, Dr. Jett and Dr. Springmeyer will combine expertise to focus on advancing the Biodesix lung cancer and nodule management programs. Springmeyer joined the company from Integrated Diagnostics (acquired by Biodesix in 2018) and Jett from Oncimmune (notice of acquisition in 2019).

"Biodesix is a natural continuation of my gratifying career as a physician. I believe that the future of patient care in oncology and pulmonology should be designed and innovated with the patient experience as the highest priority," said Dr. Jett. "I see Biodesix as a company leading the way in developing diagnostic tools that can help guide physicians and their patients to the most appropriate individual course of action."

"We continue to build a portfolio of best-in class lung nodule diagnostic tests along with a team of world class clinical experts," said Scott Hutton, chief operating officer, Biodesix. "We take lung cancer personally and by attracting the brightest minds in solving these complex diagnostic challenges we will continue to have a positive impact on physicians and their patients."

On October 8, 2019 Triumvira Immunologics (Triumvira), a privately held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, reported the issuance of key claims in U.S. Patent No. 10435453 entitled "Trifunctional T cell-antigen coupler and methods and uses thereof (Press release, Triumvira Immunologics, OCT 8, 2019, View Source [SID1234540108])." The allowed composition-of-matter claims describe multiple structures used in TAC constructs providing broad protection of the company’s TAC platform.

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Triumvira recently announced the clearance of its Investigational New Drug (IND) and Clinical Trial Applications (CTA) by U.S. and Canadian Health Authorities for its novel T cell therapy product TAC01-CD19 in patients with CD19-positive B-cell malignancies. The Phase 1/2 study (TACTIC-19, NCT03880279) is expected to be initiated in late 2019.

"Obtaining intellectual property protection of our TAC platform is a key milestone and confirms that TAC is a well-differentiated technology," said Dr. Paul Lammers, Triumvira’s President and CEO. "Issuance of our composition of matter claims further strengthens our position as a company pioneering novel engineered T cell approaches as we are bringing this innovative treatment to patients."

Triumvira’s preclinical data previously revealed unique biological differences of TAC-engineered T cells compared to second-generation CAR-T cells, with TAC-T cells producing greater anti-tumor efficacy and no evidence of toxicity, particularly in models of solid tumors.

About TAC01-CD19

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T. The first of the company’s pipeline product candidates, TAC01-CD19, is a novel T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises patient-derived T cells that have been genetically engineered to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.

On October 8, 2019 Adlai Nortye Ltd. ("Adlai Nortye" or "the Company"), a global clinical-stage biopharmaceutical company dedicated to discovery, development and commercialization of new and effective drugs with a focus on Oncology, reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress the first results from a phase 1b neoadjuvant study of AN0025 (previously known as E7046), an investigational, potentially first in class oral EP4 antagonist (Press release, Adlai Nortye Biopharma, OCT 8, 2019, View Source [SID1234540107]).

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Researchers presented results from two dose levels of AN0025 in combination with the standard of care for locally advanced rectal cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by MRI. Twenty-eight high-risk patients were enrolled with 14 patients in the 250 mg cohort and 14 patients in the 500mg cohort; 25 patients were eligible for assessment. No DLT were observed in any patients. Complete clinical responses have led to 5/25 patients being managed by a watch-and-wait approach, in those who had surgery, 4/15 had pCR with 12 of these patients having clear resection margins.

The study showed that AN0025 was well tolerated in combination with chemoradiation as well as to radiotherapy followed by consolidation chemotherapy. The preliminary efficacy demonstrated encouraging clinical results in locally advanced rectal cancer.

"There is a tremendous need for new treatment strategies in rectal cancer, especially in patients with high-risk of relapse enrolled in this study. With nearly 40% of patients not requiring surgery or achieving a complete pathological response in the post-surgical specimen in this study, AN0025 in combination with the standard pre-operative treatment warrants further development. The excellent toxicity profile of this novel immunotherapy and potential combination with both conventionally fractionated radiochemotherapy or short course irradiation with consolidating chemotherapy make this strategy feasible worldwide." said lead author Dr. Lucjan Wyrwicz, MD, PhD, Department of Oncology and Radiotherapy, M. Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland.

He added: "My patients are more and more often asking for organ preservation in rectal cancer and for many of them only a complete clinical response without any surgery is the desired outcome of treatment."

Commenting on the findings, Dr. Theodore S. Hong, MD, Director, Gastrointestinal Service, Associate Clinical Director, Department of Radiation Oncology, Massachusetts General Hospital, Co-Leader, Gastrointestinal Malignancies Program, Dana-Farber/Harvard Cancer Center, Professor of Radiation Oncology, Harvard Medical School, said "Given the unique mechanism of action and strong preclinical rationale, combined with the excellent tolerability and encouraging results, further study of AN0025 in preoperative therapy for rectal cancer are warranted. One question remains if there is a benefit to continuous exposure with AN0025 with FOLFOX followed by chemoradiation with AN0025 in a total neoadjuvant therapy (TNT) paradigm. Further evaluation in randomized trials is eagerly awaited." Dr. Hong was also an investigator in the study.

"We are very encouraged by these results and plan to move AN0025 plus chemoradiotherapy into a randomized confirmatory trial without delay" said Dr. Lars Birgerson, Chief Development Officer of Adlai Nortye. "We believe that the EP4 class, where AN0025 is a leading compound, holds considerable promise in combination with multiple treatments including check point inhibitors for a multitude of solid tumors."

About AN0025

AN0025 (previously E7046) is an investigational, potentially first in class oral EP4 antagonist that is believed to prevent the binding of prostaglandin E2 to its EP4 to change the immunosuppressive character of the tumor microenvironment. Based on preliminary results, it is well tolerated in patients with solid tumors.

On October 8, 2019 Varian (NYSE: VAR) reported that it will showcase the company’s interventional oncology solutions at the Symposium on Clinical Interventional Oncology, October 11-13, 2019 in Miami, Fla (Press release, Varian Medical Systems, OCT 8, 2019, View Source [SID1234540106]). The Varian interventional oncology portfolio encompasses cryo and microwave ablation systems, as well as embolization microspheres.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Varian is deeply committed to the ongoing development of innovative treatment solutions for clinicians offering ablation and embolization services to patients," said David Chen, vice president, Interventional Oncology Solutions, Varian. "These solutions are an important pillar of patient care and together with our clinical partners we are moving closer to creating a world without fear of cancer."

The Varian solutions on display at the Clinical Interventional Oncology event include:

Cryocare SL System and family of CryoProbes designed to deliver high-performance cryoablation technology for a number of malignant and benign conditions
MicroThermX microwave ablation systems
Portfolio of microsphere products for treating arteriovenous malformations and hypervascular tumors
Embozene Microspheres
Oncozene Microspheres
Velocity 4.0 with RapidSphere, a module for Y90 Selective Internal Radiation Therapy (SIRT) dosimetry analysis
WHERE: Booths # 300 & 302, CIO Symposium, Miami, Fla.

WHEN: Friday, October 11, 2019 through Sunday, October 13, 2019

On October 8, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its third quarter 2019 financial results on Tuesday, October 29, 2019 after the close of financial markets (Press release, Seattle Genetics, OCT 8, 2019, View Source [SID1234540105]). Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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LIVE access on Tuesday, October 29, 2019
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 800-353-6461 (domestic) or +1 334-323-0501 (international); conference ID 9057897
Webcast with slides available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Tuesday, October 29, 2019 through 5:00 p.m. PT on Friday, November 1, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 9057897
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section